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AFP RIA Kit

by Alere Inc.

PMA P760001

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 13 Jan 1984

PMA

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP760001 Date13 Jan 1984Approval withdrawnStatusWithdrawn

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Withdrawn

Specification

PMA

Generic Name
KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
FDA applicant
Alere, Inc.
PMA Number
FDA Product Code
LOK
Device Class
Class III
Advisory Committee
Immunology
FDA Decision
APWD Approval withdrawn